Action and use
Opioid receptor partial agonist; analgesic.
DEFINITION
Meptazinol Injection is a sterile solution of Meptazinol Hydrochloride in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of meptazinol, C15H23NO
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. The light absorption, Appendix II B, in the range 220 to 330 nm of the solution obtained in the Assay exhibits a maximum at 273 nm.
B. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in ethanol (96%). (1) Dilute the injection, if necessary, to contain the equivalent of 0.05% w/v of meptazinol.
(2) 0.05% w/v of meptazinol hydrochloride BPCRS.
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel F254 (Merck silica gel 60 F254 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 10 μL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).
MOBILE PHASE
1 volume of 18M ammonia, 20 volumes of absolute ethanol and 79 volumes of toluene.
CONFIRMATION
The principal spot in the chromatogram obtained with solution (1) corresponds in intensity, position and size to that in the chromatogram obtained with solution (2).
TESTS
Acidity
pH, 3.5 to 6.0, Appendix V L.
Colour of solution
The injection is not more intensely coloured than reference solution Y5, Appendix IV B, Method II.
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in water.
(1) Dilute a volume of the injection, if necessary, to produce a solution containing the equivalent of 1.0% w/v of meptazinol.
(2) Dilute 1 volume of solution (1) to 100 volumes.
(3) Dilute 1 volume of solution (2) to 2 volumes.
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating silica gel (Merck silica gel 60 F254 plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 10 μL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air, examine under ultraviolet light (254 nm), expose to iodine vapour for 2 hours and examine again.
MOBILE PHASE
1 volume of 18M ammonia, 30 volumes of chloroform and 70 volumes of ethyl acetate.
LIMITS
By each method of visualisation, any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (0.5%).
ASSAY
Dilute a suitable volume of the injection with sufficient water to produce a solution containing the equivalent of 0.01% w/v of meptazinol and measure the absorbance at the maximum at 273 nm, Appendix II B. Calculate the content of C15H23NO from the absorbance obtained using a 0.01% w/v solution of meptazinol hydrochloride BPCRS and from the declared content of C15H23NO in meptazinol hydrochloride BPCRS.
LABELLING
The label of the sealed container states the quantity of Meptazinol Hydrochloride contained in it in terms of the equivalent amount of meptazinol.
